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BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Recalled December 3, 2025 · FDA recall Z-0602-2026 · BioFire Diagnostics
Hazard
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. · FDA Class II
Units
97 Kits (2,910 pouches)
Sold at
US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
Description
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Product
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Manufacturer(s)
BioFire Diagnostics, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →